Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.
Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.
Strategic Leadership:
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Develop and execute regional regulatory strategies aligned with global business goals for new product development, lifecycle management, and market expansion.
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Serve as the primary liaison with regional regulatory authorities, managing communications, negotiations, and submission strategies.
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Monitor and anticipate regulatory trends and changes across the key markets (China, Japan, India, Korea, ASEAN, ANZ), proactively adapting strategies to maintain compliance and competitive advantage.
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Provide expert regulatory guidance to senior leadership and cross-functional teams on pathways, risk mitigation, and product positioning.
Team Management & Development:
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Lead, manage, and develop a high-performing regional regulatory team, fostering a culture of accountability, collaboration, and continuous improvement.
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Guide teams on country-specific requirements (e.g., NMPA, PMDA, MFDS, CDSCO, HSA, TGA).
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Set clear objectives, provide coaching and mentorship, and support career development for direct reports.
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Ensure effective resource allocation and workload distribution across the team to meet business priorities.
Operational Excellence:
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Oversee the preparation, submission, and maintenance of regional regulatory filings (e.g., DMF/CDMFs, SMFs, IDLs etc), ensuring quality and timeliness.
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Ensure robust regulatory documentation systems and compliance with global standards (e.g., eCTD, ICH guidelines).
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Collaborate with internal stakeholders (R&D, Quality, Clinical, Operations, Commercial) to ensure regulatory requirements are integrated throughout the product lifecycle.
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Establish and monitor KPIs to drive continuous improvement in regulatory operations and performance.
Innovation & Digital Transformation:
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Champion the use of digital tools and data analytics to enhance regulatory intelligence, submission efficiency, and decision-making.
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Identify and implement innovative approaches to streamline regulatory processes and interactions.
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Promote a mindset of agility and innovation within the regulatory fu
If you identify yourself in this position, please apply by uploading your resume and let's start the journey together!
Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.
Roquette strives to create a dynamic workforce while remaining firmly committed to equal opportunity by complying with EEO laws.
As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach.
To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com
